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Not yet recruitingNCT06459622Updated Jun 14, 2024

Predictive Factors in Chronic Rhinosinusitis With Nasal Polyps

An interventional study of Serum IL_25 and eosinophils in nasal polyp tisuee in Chronic Rhinosinusitis With Nasal Polyps, sponsored by Katrina Atef Habashy. Not yet recruiting. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-14.

Sponsored by Katrina Atef Habashy · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Mar 2025, 1 year 8 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
102
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

The study will be conducted to identify factors predicting the response of chronic rhinosinusitis with nasal polyps ( CRSwNP) to oral corticosteroids.

Read the detailed description

Treatment of nasal polyposis is divided into medical or surgical treatment .

Steroids are widely used as the most effective medicine in nasal polyposis. Although oral corticosteroids are one of the frequently used treatments in the management of chronic rhinosinusitis with nasal polyps (CRSwNP), there is lack of effective means of predicting corticosteroid sensitivity in those patients. It was reported that the overall sensitivity rates of corticosteroid therapy to nasal polyps( NP) were only between 53.8% and 80%.. Many reports stated that serum and tissue interleukeine 25 (IL 25) and serum and tissue eosinophalia are good predictors to the response of CRSwNP to oral corticosteroids.

Interleukeine 25(IL-25), an important epithelial-derived proinflammatory cytokine, plays various roles in different inflammatory and allergic diseases, such as asthma and atopic dermatitis .

Hong et al demonstrated that the levels of IL-25 in NP tissues and in serum, as well as the NP endoscopic scores, were significantly elevated in the corticosteroid-sensitive patients compared with the non-sensitive ones. In general, eosinophilic NPs are pharmacologically glucocorticoid responsive, but non-eosinophilic or neutrophilic CRSwNP is frequently resistant to steroid treatment.

02

Conditions studied

  • Chronic Rhinosinusitis With Nasal Polyps
03

In context

Nasal Polyps

236 studies on the registry are indexed under Nasal Polyps; 68 are open to participants now.

This study's planned enrollment of 102 is above the median of 60 across 181 interventional studies indexed under Nasal Polyps.

Browse Nasal Polyps studies →

Lead sponsor

This is the only study on the registry with Katrina Atef Habashy as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • clinical diagnosis of chronic rhinosinusitis with nasal polyps

Exclusion criteria

Exclusion Criteria:

  • 1-Patients who had taken any , antihistamine or other immune-modulating medications within the past 4 weeks

    2- previous nasal and sinus surgery.

    3-Allergic Fungal rhinosinusitis.

    4-Unilateral rhinosinusitis.

    5- Antrochoanal polyps or cystic fibrosis.

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
102 participants (estimated)

Study arms

  • Experimental
    Sensitive to corticosteroids

    Patients who are sensitive to corticosteroids have high serum IL-25

    Diagnostic Test: Serum IL_25 and eosinophils in nasal polyp tisuee

  • Experimental
    Non sensitive to corticosteroids

    Patients who aren't sensitive to corticosteroids have low serum IL-25

    Diagnostic Test: Serum IL_25 and eosinophils in nasal polyp tisuee

Interventions

  • Diagnostic testSerum IL_25 and eosinophils in nasal polyp tisuee

    Serum IL-25 and eosinophils in nasal polyps tisuer obtained and measured to identify the sensitivity of nasal polyps to corticosteroids

06

What researchers measure

Primary outcomes

  1. Serum IL-25 is measured to releave the relation between them and the response of CRSwNP to oral corticosteroids

    Serum IL-25 is related to the effect of corticosteroids on CRSwNP

    Time frame: Baseline

Other outcomes

  1. Eosinophils in nasal polyp tissue

    Eosinophils is related to the inflammatory process of CRSwNP

    Time frame: Baseline

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Shin HW, Kim DK, Park MH, Eun KM, Lee M, So D, Kong IG, Mo JH, Yang MS, Jin HR, Park JW, Kim DW. IL-25 as a novel therapeutic target in nasal polyps of patients with chronic rhinosinusitis. J Allergy Clin Immunol. 2015 Jun;135(6):1476-85.e7. doi: 10.1016/j.jaci.2015.01.003. Epub 2015 Feb 25. PubMed 25725991 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jul 2024; primary completion for Mar 2025, 8 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 31, 2024
First posted
Jun 14, 2024
StartEst.
Jul 2024
Primary completionEst.
Mar 2025
CompletionEst.
May 2025
Last update
Jun 14, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 14, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06459622
Lead sponsor
Katrina Atef Habashy
Collaborators
Assiut University
Responsible party
Katrina Atef Habashy (Predictive factors in response of chronic rhinosinusitis with nasal polyps to corticosteroids, Assiut University) — Sponsor-investigator
First posted
Jun 14, 2024
Start date
Jul 2024 (estimated)
Primary completion
Mar 2025 (estimated)
Completion
May 2025 (estimated)
Last update
Jun 14, 2024

Study contacts

Katrina Atef, General practitioner
Contact
Katyatef90@gmail.com
01220058161
Alla Kamel, Professor
Contact
alaakamel@med.aun.edu.eg
01005534200

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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